CBD products marketed for medical purposes
Products containing cannabidiol (CBD) used for medical purposes are medicines. If a company markets a CBD containing product that makes a medicinal claim it will be considered to fall within the definition of a medical product contained in The Human Medicines Regulations 2012.
Medicinal products must hold a Marketing Authorisation to allow their legal sale, supply, or advertisement in the UK (unless exempt). Authorised medicinal products must meet safety, quality, and efficacy standards as part of the authorisation process in place to protect public health.
It is for companies to consider whether they wish to market products that they regard to fall outside the definition of a medical product which are subject to regulation elsewhere (e.g. under food law). We will not provide advice about other regulatory regimes that can apply to products which they may choose to market, but strongly encourage them to seek advice from the relevant authorities. It is responsibility of those marketing a product to ensure that it is marketed in accordance with the relevant legislation.
MHRA can give no assurance that any particular product, including products under development, will not subsequently be classified as a medicinal product. Should companies wish to provide us with evidence that demonstrates that the products fall outside the definition of a medicinal product, then we are happy to consider this in the context of the ongoing work we are undertaking.
Our primary concern is patient safety. While products containing CBD used for medical purposes are medicines, we have also carefully considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions. Individuals doing so should discuss their treatment with their doctor.
The advice contained within this letter relates to the MHRA’s opinion regarding the status of CBD. Companies must ensure that their products comply with the relevant regulations at all times, and be mindful of the possibility that products may contain residual levels of THC which is a controlled substance.
The Home Office can advise on psychoactive substances and the misuse of drugs Act and any products which are subject to these regulations. For further information see Cannabis, CBD and other cannabinoids: drug licensing factsheet.
CBD status as a novel food
The Food Standards Agency (FSA) confirmed the novel food status of CBD in January 2019. CBD food products require authorisation before they can be sold legally in the UK. For further information see Cannabidiol (CBD) guidance for England and Wales.
Background
- This opinion is restricted to products containing cannabidiol (CBD).
- MHRA advised manufacturers and suppliers of CBD products that we were reviewing the regulatory status of CBD products prior to this opinion being issued.
- The assessment of whether a product is classified as a ‘medicinal product’ is carried out in accordance with the definition of a medicinal product and is not based on whether the product is a risk to consumers. Once a valid application is made the product will be assessed in terms of its safety quality and efficacy in the medical claims made.
- Unless exempt, medicines must have a marketing authorisation (product licence) before being placed on the market. Exempt products may be supplied as ‘specials’ by an appropriate prescriber. A ‘special’ can only be supplied in order to meet the special needs of an individual patient and may not be advertised. More information about the ‘specials’ process is available on our website.
- The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks.
